1. Field of the Invention
The present invention relates to surgical suture-needle packages, and more particularly to a needle shield device for protecting the tip of the needles from damage and to eliminate the possibility of accidental puncturing of the outer envelope enclosing the needled sutures retained therein.
2. Discussion of the Prior Art
Packaging devices for needles and suture needle assemblies generally include a retainer to enclose or hold the needles and/or sutures, and an outer envelope in which the retainer is sealed. The outer envelope maintains the sterility of the needles and sutures. In some cases a foil outer pouch is used so as to maintain a constant atmospheric condition inside the envelope to prevent drying of the suture. The retainer generally includes a fold-over flap or a cover which at least partially encloses the needles or the needle tips in the package. In many cases, the flap is integrally formed as part of the retainer so that the flap or cover comprises a tear away portion which exposes the needles upon opening of the retainer.
Several tear away type needle covers for use with surgical suture-needle assembly retainers are provided in the prior art. These retainers generally comprise a panel having either perforations or score lines which facilitate tearing a portion of the panel from the retainer to expose the needles after the retainer is opened. After the tear away cover or flap is removed, the needle and suture assembly may be removed from the retainer in the conventional manner.
In the prior art, several retainers having tear away cover flaps are disclosed, such as U.S. Pat. No. 4,063,638 to Marwood. The retainer in Marwood comprises a three panel retainer, where the suture is wound and held at the center panel and the needle is held in an outer panel. A panel having the tear away flap is provided on the outer panel opposite the needle retaining panel, and the tear away flap is folded over the sutures followed by the needle retaining flap. Upon opening the retainer, the flap is torn away, thus revealing the needle so that the needle may be removed in the conventional manner.
U.S. Pat. No. 4,406,363 to Aday, U.S. Pat. No. 4,412,614 to Ivanov et at., and U.S. Pat. No. 4,427,109 to Roshdy disclose retainers with tear away flaps or covers similar to that disclosed in Marwood above.
Another type of retainer prevalent in the prior art provides a fold over flap which covers the needles within the package. When the package is opened, the fold over flap is unfolded to reveal the needles so that the needles may be removed in the conventional manner. Such a device is disclosed in U.S. Pat. No. 4,574,948 to Huck et at., which provides a retainer in which the suture-needle assembly is secured on one panel and the needles are secured on a second panel. A fold-over flap is provided to cover the needles to prevent pricking of the user and to prevent damage to the needle tips. As the retainer is opened, the fold over flap is unfolded or tom to reveal the needles so that the needles may be removed in a conventional manner. A similar type device is disclosed in U.S. Pat. No. 4,708,241 to Black.
Other fold over cover flaps for retaining devices are disclosed in U.S. Pat. No. 4,120,395 to Mandel et al., U.S. Pat. No. 4,391,365 to Batchelor, and U.S. Pat. No. 4,884,681 to Roshdy et al. Mandel et al. and Roshdy et al. disclose a cover flap to which the needles are attached, so that as the flap is folded over the needles are covered and protected. Batchelor discloses a device similar to Huck et al. above.
Another type of suture retainer employs a configuration which comprises a coiled passageway for containing a length of suture thread. The thread is attached to a needle positioned along side the outer surface of the retainer. A retainer of this type is described in U.S. application Ser. No. 07/566,263 filed Aug. 13, 1990.
The devices disclosed in the prior art suffer from several disadvantages in which the risk of accidental pricking of the user's finger by the needle point is not significantly reduced or eliminated, especially where the needles are positioned on the outside of the retainer and have exposed tips. Further, many of these devices suffer a disadvantage in that the cost of packaging is increased due to the necessity for additional packaging material as well as increasing the number of packaging steps during assembly.
Another problem associated with the exposed needle tip is that it may puncture the outer envelope, thereby allowing entry of contaminants or release of volatile treating agents. A conditioning agent is usually incorporated into packages for certain types of sutures (e.g. collagen sutures) to keep them supple and to maintain good handling characteristics. Because the conditioning agent includes volatile liquid, the retainer and needled sutures need to be enclosed in the impermeable foil envelope, which is sealed air tight around its periphery. In use, the surgeon tears open the foil envelope, removes the retainer, then removes a needle, thereby pulling the suture out of the retainer.
When the suture packages are stacked and handled during shipment, it is possible for the sharp point of the needle to penetrate the outer foil package. Such a puncture will compromise sterility and, in the case of collagen sutures, will permit the volatile conditioning fluid to escape by means of evaporation, thus resulting in drying of the sutures and thereby rendering them unusable.